Natural medicines: will federal regulations help or hinder the natural products industry?

• Author: Micozzi, Marc S.

Editor's note: Marc Micozzi was a keynote speaker at the 1998 Mansfield Conference titled "The Healing Arts in American and Asian Cultures: A Conference on Living and Dying Well." This article was adapted from this lecture.

American consumers are rediscovering the appeal of natural medicines. From herbal remedies, to traditional Chinese medicine, to homeopathic treatments, people across the nation are spending their money on natural remedies to protect and enhance their health. "Rediscovered" is the key word because humans have used such products for millennia. Today, scientists, the media, and patients are interested in the possibility that a botanical may hold the key to curing such dreaded diseases as cancer or AIDS. However, without a focused, well-financed research program on natural medicines, and new federal regulations which treat these substances as medicines rather than foods, the full promise of these approaches may never be fulfilled.

As a physician, I believe that doctors are healers first. To help a client, they will use any ethical treatment that has been clinically proven to work. At present, these threshold criteria must eliminate many natural medicines because we don't have reliable information about their safety, efficacy, and formulations. For health care consumers, the situation may be even more frustrating. In many traditional societies, one or more members of a community may be experts on the properties and performance of natural medicines. But in contemporary America, consumers are on their own. Americans confront a bewildering variety of products that can differ significantly in their quality, usefulness, and sophistication, leaving consumers to sift through, sort out, and shift for themselves. Some might view this situation as purely the triumph of a free market, but from my perspective, this constitutes a potential health hazard that should concern everyone. From my perspective, the public health dimensions of the problem are important enough to justify a "crash program" of research. One complementary benefit of such an effort is that the natural products industry, which has received little help from the federal government to date, would ultimately have information that could help promote its products.

Natural vs. Pharmaceutical Remedies

The vast majority of natural remedies cannot be patented in the same way as products of the nation's pharmaceutical industry. This, in turn, provides little incentive for manufacturers to test and research their own products. It is also one reason that these remedies are regulated as foods rather than pharmaceuticals.

Critics contend that the industry is composed of agnostics - those who don't know and seemingly don't want to know the impact their products have on...